On 11 April 2024, on the occasion of the International Day for Maternal Health and Rights, the Medicines Patent Pool announced the signing of a memorandum of understanding (MoU) with Ferring Pharmaceuticals that includes a conditional licence agreement for heat-stable carbetocin (HSC). The MoU aims to support expanded access to HSC and is aligned with wider efforts of Unitaid, Ferring and other organisations to reduce maternal mortality.

The MoU with MPP sets out the circumstances in which Ferring will grant a non-exclusive, non-transferable, royalty-free licence of Ferring’s patents and know-how covering HSC to MPP for MPP to enter into sublicences in respect of the registration, manufacture and supply of HSC to the public sector of target countries. These countries include all L&LMICs, per the World Bank Classification, and upper middle-income countries where the maternal mortality ratios are higher than 140 per 100,000 live births, the capability to maintain cold chain is an issue, and/or where price represents a barrier to access.

The licence and the right to grant a sublicence will be triggered if and when three criteria are met. These are:

  1. HSC for the treatment of PPH is included in relevant WHO guidelines on PPH;
  2. At least one stringent regulatory authority (SRA) has approved an extension of the HSC product label to include PPH treatment; and
  3. Confirmed orders of HSC by Ferring and/or its authorised distributors to the public sector of the target countries reach a threshold of ten million ampoules per year.
Key Features
Technology Patents (including patents applications) relating to heat-stable carbetocin and know-how relating to the development or manufacture of the product.
Scope of the grant The licence agreement grants MPP a non-exclusive, royalty-free licence over Ferring’s patents and know-how with the ability to grant non-exclusive, royalty-free sublicences to eligible sublicensees for purpose of making and supplying the product for use in defined field and territory.
Field of use The prevention and treatment of post-partum haemorrhage.
Territory The target countries of the licence agreement are:

  1. public sector in low-income countries (LICs) and lower middle-income countries (LMICs); and
  2. public sector in upper middle-income countries (UMICs) if they have a maternal mortality rate > 140/100,000 women and either:

a) their capability to maintain cold chain is an issue; or

b) the normal commercial price for HSC would constitute an impediment to access in the public sector.

(Country classifications defined as per the World Bank Classification).

Manufacturing The licence agreement allows for multiple sublicensees to manufacture the product anywhere in the world solely for use in the field in the territory.
Sales outside the licensed territory The licence agreement does not restrict sublicensees from engaging in any activities that would not infringe a licensed patent granted and in force, including, without limitation, where a country has issued a compulsory license on a licensed patent.
Quality assurance Sublicensees must manufacture in a manner consistent with WHO Pre-qualification (PQ) or Stringent Regulatory Authority (SRA) standards, and good distribution practice and good manufacturing practice.  Sublicensees must obtain WHO PQ or approval from an SRA prior to sale of the product.